DementiaNCT05634317
Supporting Caregivers of PWD and Identifying an Effective Intervention to Reduce Their Depressive Symptoms
A study testing Smartphone delivered Behavioral activation and Smartphone delivered Mindfulness in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Effective clinical management of chronic conditions like depressive symptoms of caregivers actually requires a sequence of interventions, each adapts to responses to prior interventions, and hence multiple intervention decisions throughout the whole careers of dementia caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Smartphone delivered Behavioral activation and Smartphone delivered Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2022to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 or above
- FC of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community;
- having been providing care for at least 3 months prior to recruitment
- the presence of mild-to- moderate depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) score 5 to 14).
Who cannot join
- having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention 6 months prior to recruitment
- having acute psychiatric and medical comorbidities that are potentially life- threatening or would limit the caregivers' participation or adherence (e.g., suicidal ideation, acute psychosis).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic Univeristy
Hong Kong
Patrick Kor, 27665622, patrick.kor@polyu.edu.hk
About this study
Official title: Supporting Family Caregivers of People With Dementia and Identifying an Effective Adaptive Intervention to Reduce Their Depressive Symptoms: a Sequential Multiple Assignment Randomized Trial
Effective clinical management of chronic conditions like depressive symptoms of caregivers actually requires a sequence of interventions, each adapts to responses to prior interventions, and hence multiple intervention decisions throughout the whole careers of dementia caregivers. The main objective of this study is to build the capacity in the community to support the family caregivers of PWD and identify a 2-stage adaptive intervention involving behavioral activation and mindfulness practice to reduce their depressive symptoms using SMART design. A random sample of 272 family caregivers of PWD who meet the clinical criteria of subthreshold depression will be recruited. Participants will be assessed at T1 (baseline assessment); T2 (immediately after the first stage intervention); T3 (immediately after the 2nd stage intervention); T4 (3 months after the 2nd stage intervention); T5 (6 months after the 2nd stage intervention) with various health-related outcomes. The findings will inform us whether the SMART is efficient in identifying an effective adaptive intervention for reducing depressive symptoms. More importantly, will also show us how to alleviate the negative impact of caregiving in the family caregivers.
Read the detailed description
Aims The main objective of this study is to build the capacity in the community to support the family caregivers of PWD and identify a 2-stage adaptive intervention involving behavioral activation and mindfulness practice to reduce their depressive symptoms using SMART design. Using a sequential multiple randomized trial (SMART), we aim to investigate whether (1) the smartphone-delivered behavioral activation (SD-BA) or smartphone-delivered mindfulness practice (SD- MP) is more effective for reducing depressive symptoms as the first-stage intervention; (2) evaluate whether extending the original first stage intervention with an additional self-efficacy enhancing component or switching to an alternative intervention is more effective in reducing depressive symptoms when participants are not responding to the first stage intervention; (3) evaluate the sequence of the intervention, SD-BA followed by SD-MP or SD-MP followed by SD-BA is more effective in reducing depressive symptoms; and 4) identify which of our four embedded adaptive interventions (SD- BA with booster for responders and (SD-BA for nonresponses; SD-BA with booster for responders and SD-MP for no responders; SD-MY with booster for responders and SD-MP for non-responders; SD-MP with booster for responders and SD-BA for non-responders) is the most effective for reducing depressive symptoms.
Methods A random sample of 272 family caregivers of PWD who meet the clinical criteria of subthreshold depression will be recruited. Participants will be assessed at T1 (baseline assessment); T2 (immediately after the first stage intervention); T3 (immediately after the 2nd stage intervention); T4 (3 months after the 2nd stage intervention); T5 (6 months after the 2nd stage intervention) with various health-related outcomes.
Significance and value The findings will not only inform us whether the SMART is an efficient approach for identifying an effective adaptive intervention for reducing depressive symptoms, but , more importantly will also show us how to alleviate the negative impact of caregiving in the family caregivers.
- Conditions
- Dementia
- Being tested
- Smartphone delivered Behavioral activation, Smartphone delivered Mindfulness
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone delivered Behavioral activationBehavioural
Outline:
Session 0 45-minute psychoeducation on caregiving and depression
Session 1 Review the present use of time and use the monitoring form
Session 2 Brain-storm pleasant events and schedule pleasant activities
Session 3 Review scheduling of events and discuss how to improve
Session 4 Review modifications and consolidate gains on scheduling
Session 5 Review present social support and explore new sources of support
Session 6 Examine communication skills and explore new options
Session 7 Review new communications and discuss how to improve
Session 8 Review modification and consolidate gains on support
Smartphone delivered MindfulnessBehavioural
Outline:
Session 0 45-minute psychoeducation on caregiving and depression
Session 1 The Raisin exercise (eating meditation) and12-min body scan
Session 2 Exercises on thoughts and feelings 12-min body scan
Session 3 Exercises focusing on unpleasant experiences, practicing seeing and hearing , sitting meditation, 3-min breathing space, and mindful stretching and breath meditation
Session 4 Practicing seeing and hearing, mindful communication, 3-min breathing space, and sitting meditation
Session 5 Mindful walking, 3-min breathing space, and sitting meditation
Session 6 Sitting meditation, exercises on thoughts and alternative viewpoints, and 3-min breathing space (responsive)
Session 7 Sitting meditation, activity and mood exercise, identifying habitual emotional reactions to difficulties, and 3-min breathing space (responsive)
Session 8 12-min body scan, exercise on looking forward, and exercise on preparing for the future
| Study group | Role | What they receive |
|---|---|---|
| Behavioral activation | Experimental | The SD-BA, consisting of 16 sessions (30 minutes each) twice a week over 8 weeks, will be delivered by the trained instructor through a videoconference mobile app. Participants will be asked to review their daily activity patterns and then choose activity goals and review their successes and areas of improvement. They will also be taught how to fill out the daily monitoring record, which will involve noting down their activities on the day of the session for each hour before the session, and rating the importance and degree of enjoyment associated with each activity. Receives: Behavioral: Smartphone delivered Behavioral activation |
| Mindfulness | Active comparator | A mindfulness instructor will deliver the program through a videoconference mobile app, and include various mindfulness practices (e.g., mindful walking, body scanning) and sharing. To standardize the interventions in this study, the previous approach will be changed from 7 weekly 120-minute sessions to 16 sessions (30 minutes each) twice a week over 8 weeks. The participants will also be encouraged to perform 30 minutes of mindfulness practice every day. All participants will be given an audio (mp3) recording of guided mindfulness activities to enhance their daily practice, and a logbook via a mobile app or in hardcopy (according to their preference) to record the frequency of their self-practice at home and monitor their compliance rate. Our volunteers will provide support via smartphone to answer questions and address difficulties. Receives: Behavioral: Smartphone delivered Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9)
PHQ-9* is a 9-question instrument to screen for depression. It requires participants to answer their depression experiences over the past 2 weeks.
Comparisons of changes of the Patient Health Questionnaire 9 will be considered as follows:
T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5
Measured: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Secondary outcomes (4)
Perceived caregiving stress (PSS)
Perceived Stress Scale contains 10 items with 5-point Likert-type scale rating from 0 (never) to 4 (very often). The total score can range from 0 to 40 with higher scores indicating higher perceived stress.
Comparisons of changes of the perceived caregiving stress will be considered as follows:
T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5
Measured: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Positive Aspect of Caregiving scale (PAC)
The PAC scale demonstrates the acceptable levels of internal consistency Cronbach's alpha 0.85 among the family caregivers of PWD in Hong Kong. Higher scores indicating more positive self-perceptions of caregiving.
Comparisons of changes of the positive aspect of caregiving scale will be considered as follows:
T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5
Measured: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score.
Comparisons of changes of the Pittsburgh sleep quality index will be considered as follows:
T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5
Measured: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
The WHOQOL-OLD BREF (HK)
The WHOQOL-OLD BREF (HK) comprised 28 items and each item is rated on a 5-point Likert-type scale that ranged from 1 (very dissatisfied) to 5 (very satisfied), with a higher score indicating a better QoL.
Comparisons of changes of the WHOQOL-OLD BREF (HK) will be considered as follows:
T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5
Measured: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick KOR Pui Kin, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634317
- Sponsor's protocol ID
- TBC
- Status last verified
- Nov 2022
- First submitted
- 10 Oct 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Organization WH. Dementia: key facts. Retrieved March. 2019;31:2020.
Elderly Health Service DoHHK. Dementia. In: Health Do, editor. Hong Kong2016.
Romero-Moreno R, Losada A, Marquez-Gonzalez M, Mausbach BT. Stressors and anxiety in dementia caregiving: multiple mediation analysis of rumination, experiential avoidance, and leisure. Int Psychogeriatr. 2016 Nov;28(11):1835-1844. doi: 10.1017/S1041610216001009. Epub 2016 Jul 26.
PubMed 27457894Anand KS, Dhikav V, Sachdeva A, Mishra P. Perceived caregiver stress in Alzheimer's disease and mild cognitive impairment: A case control study. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):58-62. doi: 10.4103/0972-2327.167695.
PubMed 27011630Afram B, Stephan A, Verbeek H, Bleijlevens MH, Suhonen R, Sutcliffe C, Raamat K, Cabrera E, Soto ME, Hallberg IR, Meyer G, Hamers JP; RightTimePlaceCare Consortium. Reasons for institutionalization of people with dementia: informal caregiver reports from 8 European countries. J Am Med Dir Assoc. 2014 Feb;15(2):108-16. doi: 10.1016/j.jamda.2013.09.012. Epub 2013 Nov 12.
PubMed 24238605Zhu CW, Scarmeas N, Ornstein K, Albert M, Brandt J, Blacker D, Sano M, Stern Y. Health-care use and cost in dementia caregivers: Longitudinal results from the Predictors Caregiver Study. Alzheimers Dement. 2015 Apr;11(4):444-54. doi: 10.1016/j.jalz.2013.12.018. Epub 2014 Mar 15.
PubMed 24637299O'Dwyer ST, Moyle W, Zimmer-Gembeck M, De Leo D. Suicidal ideation in family carers of people with dementia. Aging Ment Health. 2016;20(2):222-30. doi: 10.1080/13607863.2015.1063109. Epub 2015 Jul 10.
PubMed 26161825Zabihi S, Lemmel FK, Orgeta V. Behavioural Activation for Depression in Informal Caregivers: A Systematic Review and Meta-Analysis of Randomised Controlled Clinical Trials. J Affect Disord. 2020 Sep 1;274:1173-1183. doi: 10.1016/j.jad.2020.03.124. Epub 2020 Apr 29.
PubMed 32663948Cheng ST, Li KK, Losada A, Zhang F, Au A, Thompson LW, Gallagher-Thompson D. The effectiveness of nonpharmacological interventions for informal dementia caregivers: An updated systematic review and meta-analysis. Psychol Aging. 2020 Feb;35(1):55-77. doi: 10.1037/pag0000401.
PubMed 31985249Walter E, Pinquart M. How Effective Are Dementia Caregiver Interventions? An Updated Comprehensive Meta-Analysis. Gerontologist. 2020 Nov 23;60(8):609-619. doi: 10.1093/geront/gnz118.
PubMed 33226434Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
PubMed 27461440Xu XY, Kwan RYC, Leung AYM. Behavioural activation for family dementia caregivers: A systematic review and meta-analysis. Geriatr Nurs. 2020 Sep-Oct;41(5):544-552. doi: 10.1016/j.gerinurse.2020.02.003. Epub 2020 Mar 3.
PubMed 32143964Au A, Gallagher-Thompson D, Wong MK, Leung J, Chan WC, Chan CC, Lu HJ, Lai MK, Chan K. Behavioral activation for dementia caregivers: scheduling pleasant events and enhancing communications. Clin Interv Aging. 2015 Mar 26;10:611-9. doi: 10.2147/CIA.S72348. eCollection 2015.
PubMed 25848237Au A, Yip HM, Lai S, Ngai S, Cheng ST, Losada A, Thompson L, Gallagher-Thompson D. Telephone-based behavioral activation intervention for dementia family caregivers: Outcomes and mediation effect of a randomized controlled trial. Patient Educ Couns. 2019 Nov;102(11):2049-2059. doi: 10.1016/j.pec.2019.06.009. Epub 2019 Jun 26.
PubMed 31279613Kor PPK, Chien WT, Liu JYW, Lai CKY. Mindfulness-Based Intervention for Stress Reduction of Family Caregivers of People with Dementia: A Systematic Review and Meta-Analysis. Mindfulness. 2018;9(1):7-22.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Family Caregivers of People With Dementia and Identifying an Effective Adaptive Intervention to Reduce Their Depressive Symptoms: a Sequential Multiple Assignment Randomized Trial
- ClinicalTrials.gov ID
- NCT05634317
- Acronym / sponsor ID
- TBC
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Effective clinical management of chronic conditions like depressive symptoms of caregivers actually requires a sequence of interventions, each adapts to responses to prior interventions, and hence multiple intervention decisions throughout the whole careers of dementia caregivers. The main objective of this study is to build the capacity in the community to support the family caregivers of PWD and identify a 2-stage adaptive intervention involving behavioral activation and mindfulness practice to reduce their depressive symptoms using SMART design. A random sample of 272 family caregivers of PWD who meet the clinical criteria of subthreshold depression will be recruited. Participants will be assessed at T1 (baseline assessment); T2 (immediately after the first stage intervention); T3 (immediately after the 2nd stage intervention); T4 (3 months after the 2nd stage intervention); T5 (6 months after the 2nd stage intervention) with various health-related outcomes. The findings will inform us whether the SMART is efficient in identifying an effective adaptive intervention for reducing depressive symptoms. More importantly, will also show us how to alleviate the negative impact of caregiving in the family caregivers.
Detailed description
Aims The main objective of this study is to build the capacity in the community to support the family caregivers of PWD and identify a 2-stage adaptive intervention involving behavioral activation and mindfulness practice to reduce their depressive symptoms using SMART design. Using a sequential multiple randomized trial (SMART), we aim to investigate whether (1) the smartphone-delivered behavioral activation (SD-BA) or smartphone-delivered mindfulness practice (SD- MP) is more effective for reducing depressive symptoms as the first-stage intervention; (2) evaluate whether extending the original first stage intervention with an additional self-efficacy enhancing component or switching to an alternative intervention is more effective in reducing depressive symptoms when participants are not responding to the first stage intervention; (3) evaluate the sequence of the intervention, SD-BA followed by SD-MP or SD-MP followed by SD-BA is more effective in reducing depressive symptoms; and 4) identify which of our four embedded adaptive interventions (SD- BA with booster for responders and (SD-BA for nonresponses; SD-BA with booster for responders and SD-MP for no responders; SD-MY with booster for responders and SD-MP for non-responders; SD-MP with booster for responders and SD-BA for non-responders) is the most effective for reducing depressive symptoms.
Methods A random sample of 272 family caregivers of PWD who meet the clinical criteria of subthreshold depression will be recruited. Participants will be assessed at T1 (baseline assessment); T2 (immediately after the first stage intervention); T3 (immediately after the 2nd stage intervention); T4 (3 months after the 2nd stage intervention); T5 (6 months after the 2nd stage intervention) with various health-related outcomes.
Significance and value The findings will not only inform us whether the SMART is an efficient approach for identifying an effective adaptive intervention for reducing depressive symptoms, but , more importantly will also show us how to alleviate the negative impact of caregiving in the family caregivers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral activation | Experimental | Behavioral: Smartphone delivered Behavioral activationThe SD-BA, consisting of 16 sessions (30 minutes each) twice a week over 8 weeks, will be delivered by the trained instructor through a videoconference mobile app. Participants will be asked to review their daily activity patterns and then choose activity goals and review their successes and areas of improvement. They will also be taught how to fill out the daily monitoring record, which will involve noting down their activities on the day of the session for each hour before the session, and rating the importance and degree of enjoyment associated with each activity. |
| Mindfulness | Active comparator | Behavioral: Smartphone delivered MindfulnessA mindfulness instructor will deliver the program through a videoconference mobile app, and include various mindfulness practices (e.g., mindful walking, body scanning) and sharing. To standardize the interventions in this study, the previous approach will be changed from 7 weekly 120-minute sessions to 16 sessions (30 minutes each) twice a week over 8 weeks. The participants will also be encouraged to perform 30 minutes of mindfulness practice every day. All participants will be given an audio (mp3) recording of guided mindfulness activities to enhance their daily practice, and a logbook via a mobile app or in hardcopy (according to their preference) to record the frequency of their self-practice at home and monitor their compliance rate. Our volunteers will provide support via smartphone to answer questions and address difficulties. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 or above
- FC of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community;
- having been providing care for at least 3 months prior to recruitment
- the presence of mild-to- moderate depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) score 5 to 14).
Key exclusion criteria (2 listed)
- having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention 6 months prior to recruitment
- having acute psychiatric and medical comorbidities that are potentially life- threatening or would limit the caregivers' participation or adherence (e.g., suicidal ideation, acute psychosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone delivered Behavioral activationOutline: Session 0 45-minute psychoeducation on caregiving and depression Session 1 Review the present use of time and use the monitoring form Session 2 Brain-storm pleasant events and schedule pleasant activities Session 3 Review scheduling of events and discuss how to improve Session 4 Review modifications and consolidate gains on scheduling Session 5 Review present social support and explore new sources of support Session 6 Examine communication skills and explore new options Session 7 Review new communications and discuss how to improve Session 8 Review modification and consolidate gains on support | Behavioural | Behavioral activation |
| Smartphone delivered MindfulnessOutline: Session 0 45-minute psychoeducation on caregiving and depression Session 1 The Raisin exercise (eating meditation) and12-min body scan Session 2 Exercises on thoughts and feelings 12-min body scan Session 3 Exercises focusing on unpleasant experiences, practicing seeing and hearing , sitting meditation, 3-min breathing space, and mindful stretching and breath meditation Session 4 Practicing seeing and hearing, mindful communication, 3-min breathing space, and sitting meditation Session 5 Mindful walking, 3-min breathing space, and sitting meditation Session 6 Sitting meditation, exercises on thoughts and alternative viewpoints, and 3-min breathing space (responsive) Session 7 Sitting meditation, activity and mood exercise, identifying habitual emotional reactions to difficulties, and 3-min breathing space (responsive) Session 8 12-min body scan, exercise on looking forward, and exercise on preparing for the future | Behavioural | Mindfulness |
Primary outcome
The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9)
Time frame: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
PHQ-9* is a 9-question instrument to screen for depression. It requires participants to answer their depression experiences over the past 2 weeks. Comparisons of changes of the Patient Health Questionnaire 9 will be considered as follows: T1 - T2; T1 - T3; T1 - T4; T1 - T5; T2 - T3; T2 - T4; T2-T5 T3 - T4: T3-T5
4 secondary outcomes
Perceived caregiving stress (PSS)
Time frame: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Positive Aspect of Caregiving scale (PAC)
Time frame: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Pittsburgh Sleep Quality Index
Time frame: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
The WHOQOL-OLD BREF (HK)
Time frame: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- BackgroundOrganization WH. Dementia: key facts. Retrieved March. 2019;31:2020.
- BackgroundElderly Health Service DoHHK. Dementia. In: Health Do, editor. Hong Kong2016.
- Background: PubMed 27457894Romero-Moreno R, Losada A, Marquez-Gonzalez M, Mausbach BT. Stressors and anxiety in dementia caregiving: multiple mediation analysis of rumination, experiential avoidance, and leisure. Int Psychogeriatr. 2016 Nov;28(11):1835-1844. doi: 10.1017/S1041610216001009. Epub 2016 Jul 26.
- Background: PubMed 27011630Anand KS, Dhikav V, Sachdeva A, Mishra P. Perceived caregiver stress in Alzheimer's disease and mild cognitive impairment: A case control study. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):58-62. doi: 10.4103/0972-2327.167695.
- Background: PubMed 24238605Afram B, Stephan A, Verbeek H, Bleijlevens MH, Suhonen R, Sutcliffe C, Raamat K, Cabrera E, Soto ME, Hallberg IR, Meyer G, Hamers JP; RightTimePlaceCare Consortium. Reasons for institutionalization of people with dementia: informal caregiver reports from 8 European countries. J Am Med Dir Assoc. 2014 Feb;15(2):108-16. doi: 10.1016/j.jamda.2013.09.012. Epub 2013 Nov 12.
- Background: PubMed 24637299Zhu CW, Scarmeas N, Ornstein K, Albert M, Brandt J, Blacker D, Sano M, Stern Y. Health-care use and cost in dementia caregivers: Longitudinal results from the Predictors Caregiver Study. Alzheimers Dement. 2015 Apr;11(4):444-54. doi: 10.1016/j.jalz.2013.12.018. Epub 2014 Mar 15.
- Background: PubMed 26161825O'Dwyer ST, Moyle W, Zimmer-Gembeck M, De Leo D. Suicidal ideation in family carers of people with dementia. Aging Ment Health. 2016;20(2):222-30. doi: 10.1080/13607863.2015.1063109. Epub 2015 Jul 10.
- Background: PubMed 32663948Zabihi S, Lemmel FK, Orgeta V. Behavioural Activation for Depression in Informal Caregivers: A Systematic Review and Meta-Analysis of Randomised Controlled Clinical Trials. J Affect Disord. 2020 Sep 1;274:1173-1183. doi: 10.1016/j.jad.2020.03.124. Epub 2020 Apr 29.
- Background: PubMed 31985249Cheng ST, Li KK, Losada A, Zhang F, Au A, Thompson LW, Gallagher-Thompson D. The effectiveness of nonpharmacological interventions for informal dementia caregivers: An updated systematic review and meta-analysis. Psychol Aging. 2020 Feb;35(1):55-77. doi: 10.1037/pag0000401.
- Background: PubMed 33226434Walter E, Pinquart M. How Effective Are Dementia Caregiver Interventions? An Updated Comprehensive Meta-Analysis. Gerontologist. 2020 Nov 23;60(8):609-619. doi: 10.1093/geront/gnz118.
- Background: PubMed 27461440Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.
- Background: PubMed 32143964Xu XY, Kwan RYC, Leung AYM. Behavioural activation for family dementia caregivers: A systematic review and meta-analysis. Geriatr Nurs. 2020 Sep-Oct;41(5):544-552. doi: 10.1016/j.gerinurse.2020.02.003. Epub 2020 Mar 3.
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RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone delivered Behavioral activation and Smartphone delivered Mindfulness in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Kor (2766 5622, patrick.kor@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 9-item Chinese version of the Patient Health Questionnaire 9 (PHQ-9) (time frame: baseline assessment(T1), after the 1 stage (8th week) (T2), after the second stage (16th week)(T3), 3 months after the 2 stage (T4), and 6 months after the 2 stage (T5))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05634317, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.